Specialist, Engineering

MSD•Upper Gwynedd Township, PA

4d•$87,300 - $137,400•Hybrid

About The Position

Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. Using innovative thinking, state-of-the-art facilities, and robust scientific methodology, we collaborate to discover the next medical breakthrough. Seeking candidates for a Specialist position within our company’s research laboratories Biologics Pilot Plant (BPP) Process Engineering Tech Transfer Team. This person will work on the preparation, and support execution, of pilot-scale campaigns for the Good Manufacturing Practice (GMP) manufacture of bulk vaccine and biologics clinical drug substance supplies. This will include unit operations in either an upstream or downstream area. The ideal candidate will possess an understanding of vaccine development, process engineering, and regulatory compliance, along with excellent project management skills. Some overtime, including weekends and occasional second and third shift work, will be required. Assignments include all aspects of equipment readiness, such as qualification and preparation, along with execution during GMP campaigns.

Requirements

GMP manufacturing of biologics, vaccines, and/or process development activities.
Works well in a team environment
Working knowledge of cGMP, Quality Systems, and safety for operations
Self-motivated with the ability to work in a fast-paced and dynamic setting
Adaptability
Adaptability
Cell Cultures
cGMP Guidelines
Chemical Engineering
Electronic Batch Records
Fast-Paced Environments
GMP Compliance
Laboratory Experiments
Mammalian Cell Culture
Motivation Management
Personal Initiative
Pilot Plant Operations
Primary Cell Culture
Problem Solving
Process Engineering
Process Optimization
Process Technologies
Product Formulation
Regulatory Compliance
Self Motivation
Standard Operating Procedure (SOP) Writing
Sterile Manufacturing
Tangential Flow Filtration (TFF)
Teamwork

Nice To Haves

Organizational, problem-solving, and project management skills
Technical background in one or more process unit operations
Experience leading small teams in a matrixed organization

Responsibilities

Collaborate in multi-disciplinary project teams to ensure seamless technology transfer of vaccine and biologic processes.
Develop equipment specifications and participate in start-up activities.
Perform unit operations e.g., cell culture, virus production, microbial fermentation, tangential flow filtration, dead-end filtration, homogenization, chromatography, etc.
Prepare and review critical documentation such as standard operating procedures.
Maintain training compliance on GMP and safety initiatives.
Participate in and conduct training sessions for pilot plant staff on new processes and technologies, ensuring knowledge transfer and operational readiness.
Stay informed on industry trends and advancements in vaccine technology to contribute to continuous improvement initiatives within the organization.